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Parker Hannifin Corporation Porter Instrument Division 245 Township Line Road Hatfield, PA 19440 USA Tel: 215-723-4000
Ref. 10489600 Rev F
i
SAFETY SUMMARY
CAUTIONS Federal Law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed practitioner. The Vacuum nipple, the vacuum adapter, the vacuum shutoff valve, and the scavenging control valve are not autoclavable (Figure 2). When autoclaving the Matrx Scavenger, Parker recommends following the specific protocol of the service provider or the sterilizer manufacturer. You can use temperatures consistent with silicone, Ultem (polyetherimide), and polysulfone, that is, temperatures in the range 120°C (248°F) to 134°C (274°F). Do not autoclave “white” single-use nasal hoods, the vacuum nipple, the vacuum adapter, the vacuum shutoff valve, or the scavenger control valve.
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Table of Contents
Notes and Contact Information .........................................................................................iv Introduction .........................................................................................................................1 Intended Use ........................................................................................................................1 CE Notice .............................................................................................................................1
Section 1 Description ..........................................................................................................................2 Section 2 Installation ...........................................................................................................................3 2.1 Fresh Gas Tubing .................................................................................................................3 2.2 Vacuum Tubing ....................................................................................................................3 2.3 Matrx MDM® and RA® Analgesia Heads ............................................................................4 Section 3 Operation .............................................................................................................................4 Section 4 Changing the Hood ............................................................................................................5 Section 5 Cleaning Instructions .........................................................................................................6 Section 6 Assembly after Cleaning ....................................................................................................6 Section 7 Replacement Parts .............................................................................................................7
iii
Table of Illustrations Figure 1. Matrx Scavenger ..................................................................................................................2 Figure 2. Shutoff Connection Options .................................................................................................3 Figure 3. Direct Connection to HVE Piping System ............................................................................3 Figure 4. Installing the Retaining Clip ..................................................................................................4 Figure 5. Removing the Y from the Hood ............................................................................................5 Figure 6. Correctly Seating the Cone in the Hood ...............................................................................5 Figure 7. Assembling the Cone ...........................................................................................................6
iv
Notes and Contact Information Date Purchased Dealer Name Dealer Phone Number Notes:
1
Introduction
CAUTION
Federal Law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed practitioner. Intended Use The Matrx Scavenger is intended to deliver and remove oxygen and analgesic gas to the patient’s upper airway. It is designed for use by medical professionals trained in the administration of conscious sedation.
CE Notice
The symbol on this product indicates compliance with the Medical Device Directive of the European Community. A "Declaration of Conformity" in accordance with the Directive has been made and is on file. European Communities should contact the Authorized Representative listed below regarding any Medical Device Directive (MDD) inquiries. Direct inquiries may be made to the following addresses:
Porter Regulatory Affairs:
Parker Hannifin Corporation Porter Instrument Division 245 Township Line Road Hatfield, PA 19440 USA Tel: 215-723-4000
EU Authorized Representative: Parker Hannifin Ltd Instrumentation Products Division Riverside Road, Pottington Business Park Barnstaple, EX 31 1NP, England Phone: +44 (0) 1271-313131 Fax: +44 (0) 1271-373636
2
Section 1 Description The Matrx Scavenger is an autoclavable nitrous oxide scavenging system consisting of four parts (see Figure 1): • a Matrx nasal hood (small, medium, or large)
• a scavenging cone system
• a vacuum tubing assembly
• a fresh gas tubing assembly The design and the small number of parts precludes missassembly during cleaning and mask changes. Figure 1. Matrx Scavenger
The vacuum ports and a one-way exhalation valve make up the scavenging cone system. The vacuum tubing assembly consists of an integral Y-piece and vacuum hose. The fresh gas tubing comprises an integral Y-piece, a fresh gas tube, a slide, and a corrugated, 22 mm fresh gas connector. All components shown in Figure 1 (except single-use nasal hoods) are autoclavable.
3
Section 2 Installation 2.1 Fresh Gas Tubing Connect the Matrx Scavenger fresh gas tubing to the fresh gas outlet of the analgesia flowmeter. The 22 mm fresh gas connector of the Matrx Scavenger connects directly to a Matrx analgesia flowmeter or to one from a different manufacturer. 2.2 Vacuum Tubing Vacuum tubing lacks corrugations on the hose. A white, hard, threaded fitting, called the vacuum nipple, attaches to the tubing’s termination. The vacuum nipple connects to the vacuum shutoff valve or to the optional scavenging control valve. The shutoff valve or the scavenging control valve attaches to the vacuum adapter. See Figure 2.
Figure 2. Shutoff Connection Options
CAUTION The vacuum nipple, the vacuum adapter, the vacuum shutoff valve, and the scavenging control valve are not autoclavable (Figure 2).
The four methods to connect the vacuum adapter to a vacuum source are: 1. Direct connection to a high volume evacuation
(HVE) line. The leading diameter of the vacuum adapter is sized to fit the HVE line inlet. Remove the HVE tip and insert the vacuum adapter.
2. Vacuum source in a junction box. Manufacturers
provide junction boxes that have at least two vacuum terminals. You must use dealer-supplied hose and/or adapters to make this connection.
3. Tee into an HVE line. The vacuum adapter
diameter is stepped to accept either 1/2” or 7/16” inside diameter hose. The properly sized tee (dealer supplied) can be inserted into the HVE line ahead of the tip. Using the appropriately sized tubing supplied by the dealer, connect the scavenger to the free leg of the tee.
4. Direct connection to an HVE piping system (see
Figure 3)
a. PVC Plumbing. The scavenger vacuum shutoff valve has 1/4 NPT female pipe threads. From a plumbing supply house, purchase the proper saddle (to fit the PVC pipe), bushing, and nipple to reduce the 1/4 NPT. Following the plumbing instructions, install the saddle and the bushings. Remove the vacuum adapter from the scavenger’s vacuum shutoff valve and thread the purchased nipple into the vacuum shutoff valve. Connect the nipple to the bushing.
b. Hard copper plumbing. From a plumbing supply house, obtain a copper flush bushing with 1/4 NPT female pipe threads. Measure the inside diameter to determine the proper drill size. At the position where you plan to place the bushing, center punch the main copper pipe. Drill an 1/8” diameter hole through one wall only. Use successively larger drills until the hole’s diameter matches the outside diameter of the flush bushing. Insert the bushing, with the nipple in place, and attach the scavenging shutoff valve to the nipple.
Figure 3. Direct connection to HVE Piping System
4
2.3 Matrx MDM® and RA® Analgesia Heads If you purchase the scavenger with the shutoff valve, the supplied clip is used to support the valve at the back of the MDM® or the RA® analgesia head. See Figure 4. 1. From the rear of the head, remove the lower left
hand cover retaining screw. 2. Insert the screw through the mounting hole in the
retaining clip. 3. Install the screw, securing the retaining clip to the
machine head. 4. Snap the scavenger vacuum shutoff valve into the
retaining clip. 5. Using dealer-supplied vacuum hoses, make the
vacuum connection as previously described. Section 3 Operation 1. Check the system before operation. Ensure that:
• The fresh gas tubing is connected to the analgesia flowmeter.
• The vacuum system is connected to the vacuum
shutoff valve or the scavenger control valve.
• The vacuum shutoff valve or the scavenger control valve is connected to the vacuum system.
• The vacuum system is operating.
2. Open the vacuum shutoff valve completely.
Figure 4. Installing the Retaining Clip
Or, open the scavenger control valve, adjusting the vacuum within the green band. Note that the line between red and green is in the American Dental Association’s (ADA) recommended 45 LPM scavenging flow. Any adjustment above this level improves the scavenging efficiency.
3. Operate the analgesia machine, according to the
manufacturer’s instructions. 4. At the completion of the procedure, shut off the
vacuum shutoff valve or the scavenger control valve.
5
Section 4 Changing the Hood 1. Hold the nasal hood in one hand. 2. With your other hand, gently pull the scavenging
cone from the hood. 3. Disconnect the long sections of the gas Y and the
vacuum Y from the hard plastic cone. 4. Pinching the gas Y just behind the hose connector,
work the hood free from the gas Y. Repeat for the vacuum Y. These procedures leave the hose connectors connected to the Ys. See Figure 5.
Figure 5. Removing the Y from the Hood 5. Remove the hood from the scavenging cone. 6. Turn the new hood upside down. Place your thumbs
inside the hood.
Figure 6. Correctly Seating the Cone in the Hood 7. Gently stretch the hole in the hood over the retaining
tabs on the scavenging cone. When the cone is seated in the nasal hood properly, three segments of the cone base are visible inside the nasal hood. See Figure 6.
8. Note the natural bend of the long tubing sections of
the gas Y and the vacuum Y. Use this bend as a guide to determine a natural fit to the left and the right sides of the hood and cone assembly.
9. Pinching the hose connector in the gas Y, insert it
into the hood fully. Repeat for the vacuum Y. 10. Connect the long sections of the Y pieces to the two
ports on the scavenging cone.
6
Section 5 Cleaning Instructions You can autoclave all Matrx Scavenger components, except the components of the vacuum shutoff valve and the scavenging control valve. To ensure proper cleaning, follow the directions below.
CAUTION
When autoclaving the Matrx Scavenger components, Parker recommends following the specific protocol of the service provider of the sterilizer manufacturer. You can use temperatures consistent with silicone, Ultem (polyetherimide), and polysulfone, that is, in the temperature range from 120°C (248°F) to 134°C (274°F).
1. Remove the vacuum Y from the hood and cone. Remove the tubing from the vacuum nipple.
NOTE
Do not unthread the vacuum nipple from the shutoff valve or the scavenging control valve.
Section 6 Assembly after Cleaning
Figure 7. Assembling the Cone 1. Attach the exhalation valve to the exhalation valve
cage (see Figure 7). 2. With the exhalation valve facing the cone, insert the
assembled exhalation valve and exhalation valve cage into the cone.
3. Turn the cage counterclockwise. 4. Continue turning until the tabs engage and the pinch
bar snaps closed. When completely engaged, the cone and the cage cannot disengage.
2. Remove the fresh gas Y from the hood. Remove the
tubing from the fresh gas outlet of the gas mixing apparatus.
3. Wash each tube with a mild alkali detergent. 4. Wash the scavenging cone system with a mild alkali
detergent. Run a soft bristle brush around the inside of the cone to remove any debris. If necessary, you can detach the cone from the cage by bending the pinch bar back and turning clockwise (see Figure 7).
CAUTION
Do not autoclave “white” single-use nasal hoods, the vacuum nipple, the vacuum adapter, the vacuum shutoff valve, or the scavenger control valve.
5. Autoclave all parts not included in the CAUTION
above. Use autoclavable protocol. 5. Turn the hood upside down. Place your thumbs
inside the hood. 6. Gently stretch the hole in the hood over the retaining
tabs on the scavenging cone. When the cone is seated in the nasal hood properly, three segments of the cone base are visible inside the nasal hood. (see Figure 6).
7. Note the natural bend of the long tubing sections of
the gas Y and the vacuum Y. Use this bend as a guide to determine a natural fit to the left and right sides of the hood and cone assembly.
8. Pinching the hose connector in the gas Y (Figure 5),
insert it into the hood fully. Repeat for the vacuum Y. 9. Connect the ling section of the Y pieces to the two
ports on the scavenging cone. 10. Attach the free end of the fresh gas tubing to the
analgesia head. 11. Attach the free end of the vacuum tubing to the
vacuum nipple on the vacuum shutoff valve or on the scavenging control valve.
7
Section 7 Replacement Parts You can obtain the following replacement parts from Parker.
Matrx Part No. Description Size 91515201 Hose connectors (package of 2)
91515202 Vacuum tubing and Y assembly
91515203 Fresh gas tubing and Y assembly (including slide)
91515177 Replacement cone assembly
10489600 Instruction manual
91515199 Extension kit
91515158 Vacuum nipple (with small orifice)
91515159 Shutoff valve
91515096 Reusable hood Large
91515095 Reusable hood Medium
91515094 Reusable hood Small
See pages 8 & 9 for single-use hoods
Scavenging Control Valve (above)
91515083 For MDM® or RA®
91525109 For Digital MDM®
91515084 For Centurion Mixer
91515085 Adapter with Ohio Quick Connect
91515086 For cabinet mounting
8
DynoMite Single-use Nasal Hoods (package of 12)
Matrx Part No. Description Size
91316496 Bubble gum Small
91316503 Bubble gum Medium
91316510 Bubble gum Large
91316497 Strawberry Small
91316504 Strawberry Medium
91316511 Strawberry Large
91316498 Orange Small
91316505 Orange Medium
91316512 Orange Large
91316499 Vanilla Small
91316506 Vanilla Medium
91316513 Vanilla Large
91316500 Plain Small
91316507 Plain Medium
91316514 Plain Large
91316501 Assorted scents Small
91316508 Assorted scents Medium
91316515 Assorted scents Large
91316516 Assorted scents Various
DynoMite Single-use Nasal Hoods (package of 24)
Matrx Part No. Description Size
91316461 Bubble gum Small
91316468 Bubble gum Medium
91316475 Bubble gum Large
91316462 Strawberry Small
91316469 Strawberry Medium
91316476 Strawberry Large
91316463 Orange Small
91316470 Orange Medium
91316477 Orange Large
91316464 Vanilla Small
91316471 Vanilla Medium
91316478 Vanilla Large
91316465 Plain Small
91316472 Plain Medium
91316479 Plain Large
91316466 Assorted scents Small
91316473 Assorted scents Medium
91316480 Assorted scents Large
91316481 Assorted scents Various
9
DynoMite Single-use Nasal Hoods (24 in a decorative canister, right)
Matrx Part No. Description Size
91316482 Bubble gum Small
91316519 Bubble gum Medium
91316489 Bubble gum Large
91316483 Strawberry Small
91316520 Strawberry Medium
91316490 Strawberry Large
91316484 Orange Small
91316521 Orange Medium
91316491 Orange Large
91316485 Vanilla Small
91316522 Vanilla Medium
91316492 Vanilla Large
91316486 Plain Small
91316523 Plain Medium
91316493 Plain Large
91316487 Assorted scents Small
91316524 Assorted scents Medium
91316494 Assorted scents Large
91316495 Assorted scents Various
DATE: 4/30/09 ECN: 09-0090 DR: MAM CH: AP: SHT 17 OF 17 Scavenger Instruction NUMBER: 10489600-F REV.
Manual 10489600 F
REVISION HISTORY
Rev. Date Ecn # Description of Changes Dr Ch Appr D 4/30/09 09-0090 Updated to have Parker information. Created in
word document from PDF. MAM AEM SDL
E 3/11/10 10-0073 Changed Authorized Rep. For Ce Marked
Products From Heatherside-April Fay To Parker Hannifin Ltd Instrumentation Products Division
ANB RAR ALE
F 8/19/10 10-0235 Updated CE Mark ANB